MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TE3442A
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.H6: code b20 ¿ the device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted that, per the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, endoprosthesis migration and occlusion.Patient medication includes: albuterol, cymbalta, copaxone, losartan.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
On (b)(6) 2023, patient underwent treatment for a acute type b dissection utilizing gore® tag® thoracic branch endoprosthesis (tbe-tac083415a).Procedure was completed and a small leak was identified.Physician decided to monitor this leak.On an unknown date, a ct scan was performed which revealed a larger leak, very likely a type 1a endoleak.Physician still decided to monitor this leak, with no plans for reintervention surgery.On (b)(6) 2023, an additional ct scan was performed.The type 1a endoleak seemed to mostly resolve, however there was still a small leak that remained.On (b)(6) 2023 patient underwent reintervention surgery due to this type 1 endoleak ((b)(4) was opened to capture this type 1 endoleak requiring reintervention).On (b)(6) 2023 during reintervention surgery, a gore® tag® thoracic branch endoprosthesis (tbe aortic extender ¿ tbe te3742) was utilized to extend proximally.At the most proximal extent, the te3742 was smaller than the patient anatomy.During deployment, the aortic extender migrated proximally (about 10 mm).The aortic extender partially covered the left common carotid artery.Surgical bypass was performed to include blood flow into the carotid from the subclavian artery.Physician attributes the aortic extender moving proximally due to patient's anatomy, as anatomy was larger proximally, in relation to the stent.

• Brand Name: GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: liliian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18658311
• Report Number: 2017233-2024-04602
• Device Sequence Number: 20662131
• Product Code: MIH
• UDI-Device Identifier: 00733132654314
• UDI-Public: 00733132654314
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/08/2026
• Device Catalogue Number: TE3442A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 02/07/2024
• Date Device Manufactured: 01/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 79 KG